ISO 41064-2023 PDF

Full title and description

ISO 41064:2023 — Health informatics — Standard communication protocol — Computer-assisted electrocardiography. This International Standard specifies common conventions, content and structure for interchange of patient demographic and recording data, ECG signal data and metadata, measurements, annotations and interpretation results between electrocardiographs/devices and computer ECG management systems or other health information systems.

Abstract

This standard defines how to describe and encode medium- to long‑term electrocardiogram waveforms and associated metadata for a wide range of ECG types (for example 12‑lead, 15‑lead, 18‑lead, Cabrera, Nehb, Frank, XYZ, Holter and exercise ECGs), intracardiac electrograms and analysis/interpretation outputs compatible with the SCP‑ECG family of conventions. It is intended for interchange between ECG acquisition devices, analysis/interpretation software, device/cloud storage and ECG management systems while excluding real‑time waveform encoding for physiological monitors and detailed intra‑cardiac/extra‑cardiac mapping formats.

General information

• Status: Published
• Publication date: 27 June 2023
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 35.240.80 — IT applications in health care technology
• Edition / version: Edition 1 (2023-06)
• Number of pages: 231

Metadata and publication details as recorded by ISO (publication 27 June 2023).

Scope

ISO 41064:2023 applies to the interchange of ECG recordings, related patient and recording metadata, ECG measurements, annotation and interpretation results between acquisition devices (including electrocardiographs, patient monitors, wearables and implantable devices) and computer ECG management systems or other information systems (including cloud storage). It covers encoding and structure for standard and medium/long‑term waveforms used in clinical and ambulatory contexts, and addresses compatibility with established SCP‑ECG conventions. It does not target real‑time physiological monitor encoding nor specialized intracardiac/extra‑cardiac mapping formats.

Key topics and requirements

• Standardized message and file structure for ECG signal data and associated metadata (patient, recording conditions, device identifiers).
• Encoding rules for multi‑lead ECG waveforms (sampling, bit depth, lead configurations including 12‑lead, Cabrera, Frank and others).
• Representation of ECG measurements, annotations and interpretation results in a machine‑readable form.
• Requirements for interchange between acquisition devices, analysis/interpretation software and ECG management or cloud systems.
• Backward compatibility considerations with earlier SCP‑ECG / ISO 11073‑derived conventions where applicable.
• Explicit exclusions for real‑time physiological monitor waveform encoding and advanced intracardiac/extra‑cardiac mapping.

Typical use and users

Primary users include medical device manufacturers (electrocardiographs, Holter recorders, wearable ECGs, implantable device vendors), healthcare IT and EMR/HIS integrators, clinical informaticians, hospitals and clinics managing ECG archives, developers of ECG analysis and interpretation software, regulatory bodies reviewing device interoperability, and researchers working with large ECG datasets.

Related standards

ISO 41064:2023 replaces/updates concepts previously covered under ISO 11073‑91064:2009 and is part of the ISO health informatics work of ISO/TC 215. Related interoperability and clinical‑data standards to consider when implementing ECG interchange include the SCP‑ECG family conventions (as incorporated), wider ISO/IEEE 11073 device communications family, HL7/FHIR resource mappings for observations and diagnostic reports, and DICOM Waveform and cardiology profiles where imaging/archival integration is required. The ISO record notes the withdrawal of ISO 11073‑91064:2009 upon publication of ISO 41064:2023.

Keywords

ECG; electrocardiography; SCP‑ECG; health informatics; ECG interchange; waveform encoding; Holter; 12‑lead; intracardiac electrogram; ISO 41064; interoperability; ISO/TC 215.

FAQ

Q: What is this standard?

A: ISO 41064:2023 is an International Standard specifying a standard communication protocol and the content/structure for exchanging computer‑assisted electrocardiography (ECG) data, metadata, measurements, annotations and interpretation results between devices and information systems.

Q: What does it cover?

A: It covers encoding and conventions for medium to long‑term ECG recordings (multiple lead configurations including 12‑lead, Holter and others), related patient and recording metadata, measurement and annotation structures, and rules for interchange between acquisition devices, analysis software and ECG management or cloud systems. It excludes real‑time physiological monitor encoding and specialized intracardiac/extra‑cardiac mapping formats.

Q: Who typically uses it?

A: Device manufacturers, clinical software vendors, healthcare IT teams, hospitals and clinics, regulatory reviewers, and researchers dealing with ECG data interoperability and archival.

Q: Is it current or superseded?

A: ISO 41064:2023 was published on 27 June 2023 and is the current ISO record for this subject; it supersedes the earlier ISO 11073‑91064:2009. (Status confirmed against ISO publication metadata; current as of 1 March 2026.)

Q: Is it part of a series?

A: It is part of ISO’s health informatics deliverables under ISO/TC 215 and aligns with device communication and clinical data standards (the ISO/IEEE 11073 family and related health informatics standards). Implementers often map ECG interchange details to broader clinical‑data frameworks such as HL7/FHIR or DICOM where system integration is required.

Q: What are the key keywords?

A: ECG, electrocardiography, SCP‑ECG, waveform encoding, interoperability, health informatics, Holter, 12‑lead, ISO 41064.